For EU CE certification of medical devices, compliance with relevant standards is essential to demonstrate conformity with the essential requirements of the Medical Devices Directive (MDD) or the Medical Devices Regulation (MDR). These standards cover various aspects of device design, manufacturing, performance, and safety. Here are some key standards commonly referenced for EU CE certification of medical devices:

General Standards:

1. ISO 13485:2016 (or EN ISO 13485:2016):

   • Quality management systems – Requirements for regulatory purposes, ensuring consistent design, production, and distribution of medical devices.

2. ISO 14971:2019:

   • Application of risk management to medical devices, providing guidelines for identifying and mitigating risks throughout the device lifecycle.

Essential Requirements Standards:

1. General Safety and Performance Requirements (GSPR):
   • These are specific to each device category and are outlined in Annex I of the MDD or MDR. They cover aspects such as biocompatibility, electrical safety, mechanical safety, usability, and performance characteristics.

Specific Device Standards:

Depending on the type of medical device, additional standards may apply:

1. Biological Evaluation of Medical Devices:

   • ISO 10993 series: Biological evaluation of medical devices, covering aspects like biocompatibility testing.

2. Electrical Safety:

   • IEC 60601 series: Medical electrical equipment standards covering safety and essential performance.

3. Sterilization of Medical Devices:

   • ISO 11135: Sterilization of health care products – Ethylene oxide – Requirements for development, validation, and routine control of a sterilization process for medical devices.
   • ISO 11137: Sterilization of health care products – Radiation – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

4. Software:

   • IEC 62304: Medical device software – Software life cycle processes.
   • IEC 62366-1: Application of usability engineering to medical devices – Part 1: General requirements and evaluation of usability.

5. Packaging:

   • ISO 11607 series: Packaging for terminally sterilized medical devices, covering requirements for materials, sterile barrier systems, and validation of packaging processes.

Other Relevant Standards:

1. Clinical Evaluation:

   • ISO 14155: Clinical investigation of medical devices for human subjects – Good clinical practice.

2. Labeling:

   • ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.

Compliance with MDR Requirements:

Under the Medical Devices Regulation (MDR), additional requirements include:

1. UDI (Unique Device Identification):

   • Compliance with EU UDI requirements, as specified in EU MDR Article 27 and implementing acts.

2. Summary of Safety and Clinical Performance (SSCP):

   • Preparation and maintenance of an SSCP summarizing clinical data and post-market surveillance information.

3. EUDAMED Database:

   • Registration of device and economic operator information in the EUDAMED database, once fully operational.

Implementation:

• Selection of Standards: Choose applicable standards based on device type, intended use, and regulatory requirements (MDD or MDR).

• Documentation: Ensure technical documentation includes evidence of compliance with relevant standards as part of the conformity assessment process.

• Notified Body Involvement: For higher-risk devices (Class IIa, IIb, III under MDR), engage with a Notified Body accredited to assess conformity with these standards.

Adhering to these standards is critical for achieving and maintaining EU CE certification, demonstrating that your medical device meets essential safety and performance requirements for market access within the European Economic Area (EEA).

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